A Prospective, Multicentric, Randomized, Double Blind, Parallel, Saline Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Subjects of Acute Ischemic Stroke
| Registry | NCT04046484 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Pharmazz, Inc. (Industry) |
| Conditions | Acute Stroke, Cerebral Ischemia |
| Interventions | Normal Saline along with standard treatment, PMZ-1620 along with standard treatment (Drug) |
| Dates | start 2018-01-19, primary completion 2019-04-12, completion 2019-06-30, first posted 2019-08-06, last updated 2025-05-12 |
| Locations | 7 sites in India |
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This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute ischemic stroke.
There are hidden stem cells in the brain, which becomes active following injury to the brain. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the brain to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic activity and also increases cerebral blood flow when administered following ischemia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Normal Saline (Dose: Equal volume) + Standard of care | Active comparator | Drug: Normal Saline along with standard treatment | Patients will receive the best available standard of care. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization. |
| PMZ-1620 + Standard of care | Experimental | Drug: PMZ-1620 along with standard treatment | Patients will receive the best available standard of care. In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight). |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria:
1. Adult males or females Aged 18 years through 70 years (have not had their 71st birthday)
2. Signed and dated informed Consent from Legally Acceptable Representative, if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained on a separate informed consent form to confirm his/her willingness to continue in the study
3. Stroke is ischemic in origin, supratentorial, and radiologically confirmed Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment
4. New (first time) cerebral ischemic strokes subjects presenting upto 24 hours after onset of symptoms (mRS score of 3-4) with a prestroke mRS score of 0 or 1 and NIHSS score of 5-14)
5. No hemorrhage as proved by cerebral CT/MRI scan
6. Subject is < 24 hours from time of stroke onset when the first dose of PMZ-1620 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when subject was last seen or was self- reported to be normal
7. Reasonable expectation of availability to receive the full PMZ-1620 course of therapy, and to be available for subsequent follow-up visits
8. Subjects receiving thrombolytic therapy
9. Reasonable expectation that subject will receive standard post- stroke physical, occupational, speech, and cognitive therapy as indicated
10. Female subject is either:
* Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
* If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, OR A vasectomised partner OR abstinence
Exclusion Criteria:
1. Subjects receiving endovascular therapy
2. Subjects presenting with lacunar, hemorrhagic and/or brain stem stroke
3. Subjects classified as comatose, defined as a subject who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score must be < 2)
4. Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. (An episode of CHF is any heart failure that required a change in medication, change in diet or hospitalization)
5. Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH) on the baseline CT or MRI scan
6. Known valvular heart disease with CHF in the last 6 months
7. Known (or in the Investigator's clinical judgment) existence of severe aortic stenosis or mitral stenosis
8. Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft, (CABG), valve replacement surgery) in the last 6 months
9. Subject is a candidate for any surgical intervention for treatment of stroke which may include but not limited to endovascular techniques
10. Subjects who are obese, body mass index (BMI) > 30 and/or on hormonal contraceptives
11. Hypo- or hyperglycemia sufficient to account for the neurological symptoms; patient should be excluded if their blood glucose is < 3.0 or > 20.0 mmol/L
12. Patient has systolic BP < 90 mmHg or > 220 mmHg or diastolic BP < 40 mmHg or > 130 mmHg
13. Acute myocardial infarction in the last 6 months
14. Signs or symptoms of acute myocardial infarction, including electrocardiogram findings, on admission
15. Concomitant treatment with neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational, neuroprotecti-ve substances)
16. Qualitative estimation of troponin on admission
17. Suspicion of aortic dissection on admission
18. Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic BP < 100 mmHg)
19. Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate > 100/min) attributable to CHF; (4) lower extremity pitting edema attributable to CHF; (5) bilateral rales; and/or (6) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution
20. Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy
21. Serum creatinine > 2.0 mg/dL or 180 μmol/L
22. Severe chronic anemia (hemoglobin < 7.5 g/dL)
23. Pregnancy, breastfeeding or positive pregnancy test. (Women of childbearing age must have a negative pregnancy test prior to study drug administration)
24. Concurrent participation in any other therapeutic clinical trial
25. Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which PMZ-1620 therapy would be contraindicated or might cause harm to the subject| Facility | City | Country | Status |
|---|---|---|---|
| Paras Hospital | Gurgaon | India | |
| Nizam's Institute of Medical Sciences | Hyderabad | India | |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences | Lucknow | India | |
| Dayanand Medical College & Hospital | Ludhiana | India | |
| Department of Neurology, Christian Medical College and Hospital | Ludhiana | India | |
| New Era Hospital & Research Institute | Nagpur | India | |
| All India Institute of Medical Sciences | New Delhi | India |